NCT00635843已完成3 期
"A Prospective, Randomized Controlled Clinical Investigation of MAVERICK™ Total Disc Replacement in Patients With Degenerative Disc Disease"
Medtronic Spinal and Biologics63 个研究点 分布在 1 个国家目标入组 577 人开始时间: 2003年4月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 577
- 试验地点
- 63
- 主要终点
- Overall Success
研究概览
简要总结
The purpose of this clinical trial is to assess the safety and effectiveness of the MAVERICK™ Total Disc Replacement as a method of treating patients with lumbar degenerative disc disease at one level from L4-S1, with overall success being the primary endpoint of the clinical trial. The primary objective is to show non-inferiority of the investigational device to the control treatment. If non-inferiority is established, superiority will be examined.
详细描述
For this clinical trial, there are two treatment groups, i.e., investigational patients who receive the MAVERICK™ Total Disc Replacement and control patients who receive the anterior lumbar interbody fusion procedure with INFUSE® Bone Graft/LT-CAGE® Lumbar Tapered Fusion Device. Each investigational site will enroll patients in a 2:1 investigational:control treatment randomization scheme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has DDD as noted by back pain of discogenic origin, with or without leg pain, with degeneration of the disc confirmed by patient history
- •Has 1 or more of the following documented by CT, MRI, or plain x-rays: modic changes, high intensity zones in the annulus, loss of disc height, decreased hydration of the disc
- •Has documented annular pathology
- •Has single-level symptomatic degenerative involvement from L4-S1 requiring surgical treatment
- •Has intact facet joints at the involved vertebral levels documented by CT and/or MRI
- •Has preop Oswestry score≥30
- •Has preop back pain score ≥20
- •Age 18 to 70 yrs who are skeletally, mature, inclusive
- •Has not responded to non-operative treatment for 6 mos
- •If child-bearing potential, patient is non-pregnant, non-nursing, and agrees not to become pregnant for 1 yr after surgery
- •Is willing and able to comply with the study plan and sign the Patient Informed Consent Form
排除标准
- •Has primary diagnosis of a spinal disorder other than DDD at involved level
- •Had previous posterior lumbar spinal fusion surgical procedure at involved level
- •Had prior posterior lumbar surgery resulting in significant muscle/ligament morbidity, not including facet saving techniques
- •Had previous anterior lumbar spinal surgery at involved level
- •Requires spinal fusion and/or arthroplasty at more than 1 lumbar level
- •Has severe pathology of facet joints of involved vertebral bodies
- •Has any posterior element insufficiency
- •Has spondylolisthesis
- •Has spinal canal stenosis
- •Has rotatory scoliosis at involved level
- •Level treated has fractures secondary to trauma
- •Has any of the following that may be associated with a diagnosis of osteoporosis (if Yes, a DEXA Scan is required): Postmenopausal Non-Black female over 60 yrs of age and weighs less than 140 pounds; Postmenopausal female that has sustained a non-traumatic hip, spine or wrist fracture; Male over the age of 60 that has sustained a non-traumatic hip or spine fracture. If level of BMD is -3.5 or lower or -2.5 or lower with vertebral crush fracture, the patient is excluded
- •Has fever (temp > 101°F oral) at time of surgery
- •Has a condition that requires postop medications that interfere with fusion, such as steroids or prolonged use of non-steroidal anti-inflammatory drugs, excluding routine perioperative, non-steroidal anti-inflammatory drugs. Does not include low dose aspirin for prophylactic anticoagulation
- •Has overt or active bacterial infection, either local or systemic and/or potential for bacteremia
- •Has presence or prior history of malignancy (except for basal cell carcinoma of skin)
- •Has documented metal allergy, titanium alloy intolerance or cobalt-chrome-molybdenum alloy
- •Is mentally incompetent. If questionable, obtain psych consult
- •Has a Waddell Signs of Inorganic Behavior score of 3 or greater
- •Has chronic or acute renal and/or hepatic failure or prior history of renal and/or hepatic parenchymal disease
- •Is prisoner
- •Is pregnant
- •Is an alcohol and/or drug abuser as defined by currently undergoing treatment for alcohol and/or drug abuse
- •Has received drugs that may interfere with bone metabolism within 2 weeks prior to the surgery date, excluding routine perioperative, non-steroidal anti-inflammatory drugs
- •Has history of autoimmune disease
- •Has history of exposure to injectable collagen implants
- •Has history of hypersensitivity to protein pharmaceuticals (monoclonal antibodies or gamma globulins) or collagen
- •Has received treatment with an investigational therapy within 30 days prior to implantation surgery or treatment is planned during 24 months following the implantation surgery
- •Has received any previous exposure to any/all BMP's of either human or animal extraction
- •Has history of allergy to bovine products or a history of anaphylaxis
- •Has history of any endocrine or metabolic disorder known to affect osteogenesis
- •Has any disease that would preclude accurate clinical evaluation
结局指标
主要结局
Overall Success
时间窗: 24 Months
A patient will be considered an overall success if all of the following conditions are met: 1. pain/disability(Oswestry)success; 2. neurological status success; 3. disc height success; 4. no serious adverse event classified as "implant associated" or "implant/surgical procedure associated"; 5. no additional surgical procedure classified as a "failure".
次要结局
- Pain/Disability Status(24 Months)
- Neurological Status(24 months)
- Disc Height Measurement(24 months)
- General Health Status(24 months)
- Back Pain(24 months)
- Leg Pain(24 months)
- Patient Satisfaction(24 months)
- Patient Global Perceived Effect(24 months)
- Operative Time(At the time of operation)
- Blood Loss(At the time of operation)
- Number of Hospital Days(At the time of discharge)
研究者
研究点 (63)
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